Renal colic pain based on kidney or ureteric stones in patients of 18 years and older.
Conditions
Interventions
Trade Name: Tramadol
Product Name: Tramadol
Product Code: Tramadol
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the pla
Sponsors
Isala klinieken Zwolle
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The participants are 18 years and older and are able to make a will. Participants presenting with clinical signs and symptoms of renal colic, as ajudged by a urologist or resident in urology, are included after oral an written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -pregnancy or lactation -chronic tramadol use -severe renal failure, GFR less than 10 ml/min -severe hepatic failure -allergic reactions to opioids / NSAID's -concommitent use of MAO-inhibitor, or less than 2 weeks after stop MAO-inhibitor -narrow-angle glaucoma -use of NSAID's 8 hours before admittance -use of drugs or alcohol 8 hours before admittance -hydronephrotic kidney combined with fever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can a difference between the change in the perception of pain over time(0-60minutes) between tramadol and butylscopolamine in renal colic be proven?;Secondary Objective: -Can a difference in the decline in VAS-score over time (0-240min) between the tramadol group and the butylscopolamine group be proven? -Can the therapeutic efficacy of butylscopolamine compared to placebo over time (0-240min) be proved? -Can the therapeutic efficacy of tramadol compared to placebo over time (0-240min) be proved? -What are the side effects of continuous intravenous administered tramadol and to what extend do they occur? -Is a difference in the need for of rescue-medication seen between the tramadol and butylscopolamine group?;Primary end point(s): Efficacy of treatment is defiend as a decline of 10mm or more on the horizontal Visual Analogue Scale. Differences between the tramadol and butylscopolamine groups wil be calculated with change in VAS-score between T0 and T3 ( 60min ). | — |
Countries
Netherlands
Outcome results
None listed